Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

Wednesday, July 6, 2016 Daily Archives

CASSS, a professional biopharmaceutical society, honored longtime volunteers Frantisek Svec and Joseph Pesek as Distinguished Fellows after their retirements from the CASSS Board of Directors. At a recent luncheon, John Frenz, president of the CASSS Board, noted that Svec had “shepherded CASSS into a big evolution” that developed CASSS into a global community of biopharmaceutical professionals. Svec, the former facility director of the organic and macromolecular synthesis facility at E.O. Lawrence Berkeley Laboratory, served on the CASSS Board for more…

Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, today has signed a contract to acquire U.S. centrifuge specialist kSep Holdings, Inc. (kSep). The privately owned company based in Morrisville, NC, has been operating on the market since 2011, and is expected to achieve significant double-digit growth and to generate around $7 million sales revenues and a strong double-digit EBITDA margin in 2016. The transaction values kSep at around $28 million and will be closed by the…

Eppendorf expands its portfolio of rigid-wall single-use vessels for fermentation. The newly launched Eppendorf BioBLU® 3f was developed specifically for microbial bioprocessing in working volumes of 1.25 to 3.75 L, extending the full range of operation for single-use fermentation from 60 mL to 3.75 L. Eppendorf BioBLU f Single-Use Vessels specifically address the demands of high cell density fermentation of bacteria, yeasts, and fungi. Robust magnetic overhead drives featuring Rushton-type impellers support agitation rates up to 1200 rpm and provide…

LEWA became the first to market with a twin column low pressure chromatography system at the pilot scale designed for use in GMP environments with its recent shipment to the Fraunhofer Institute for Interfacial Engineering and Biotechnology (Stuttgart, DE). The GMP scale unit (EcoPrime® Twin LPLC) can be configured to allow drug manufacturers to use a twin column unit in multiple modes: full continuous purification, integrated (continuous) batch and batch – with built in capability to operate columns in series,…